Understanding Experiences of People With Spinal Cord Injury Undergoing Activity-based Rehabilitation
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|ClinicalTrials.gov Identifier: NCT04000256|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2019
Last Update Posted : April 7, 2023
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|Condition or disease||Intervention/treatment|
|Spinal Cord Injuries||Behavioral: Activity based rehabilitation|
Incomplete cervical spinal cord injury (SCI) makes up half of all the newly admitted patients. The overall prognosis for walking is better than the upper limb recovery in incomplete tetraplegia. Upper limb deficits result in difficulty in managing daily activities and self-care and impacts quality of life. Rehabilitation of the upper limb involves high intensity repetitive activities that are directed to a specific task. The demands of these programs can be up to 5 hours of therapy, 5 days a week for 12 weeks. Home-based therapies augmented by tele-rehabilitation presents a more realistic alternative to clinic-based application of these programs due to transportation and time commitment. However, engaging and motivating therapy options are needed for home to enhance client outcomes and improve compliance. Some of the latest equipment provides this capability and engages the patient using games for training. However, high equipment cost limits its widespread use.
In this study, we will engage individuals with cervical SCI in a 4-week (8 visit) evaluation of a variety of training protocols to gather information on their perceptions regarding motivation, engagement, and challenge it offers; its ability to address limitations they experience; and its feasibility within the home.
The long-term goal of this National Institute of Disability Independent Living and Rehabilitation (NIDILRR) funded Spinal Cord Injury Model System (SCIMS) project is to develop an engaging and evidence-informed intervention for home-based upper limb activity-based rehabilitation in individuals with spinal cord injury (SCI). A review of literature was recently conducted by the research team to get a scope of the evidence related to current activity-based therapies and the equipment used to deliver these programs. There is insufficient information about the value of high-end equipment involving games relative to lower cost alternatives, or the perceptions of clients regarding the use of various technologies related to motivation, engagement, appropriate level of difficulty and feasibility within the home. This lab-based study aims to understand the experiences related to rehabilitation training and high and low end equipment for upper limb activity-based rehabilitation in individuals with spinal cord injury.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Understanding Experiences of People With Spinal Cord Injury Undergoing Activity-based Rehabilitation|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||June 15, 2024|
|Estimated Study Completion Date :||June 15, 2024|
Spinal Cord Injury
The data during the first visit involves questionnaires, performance and observational measures for baseline evaluation. The 2nd to 8th visit involves feedback survey and interview data collection based on experiences of participants undergoing activity-based training using upper extremity rehabilitation equipment.
Behavioral: Activity based rehabilitation
Activity based rehabilitation for the upper extremity involves various gross and fine movements, reach and object transportation, and object manipulation. The rehabilitation equipment used during training will include gaming and instrumented training equipment, conventional table-top tasks, and exercise aids.
- 10-item questionnaire [ Time Frame: Week 4 ]Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.
- Qualitative interview [ Time Frame: Week 4 ]Interview to explore further the experiences with rehabilitation training and equipment.
- Qualitative interview [ Time Frame: Week 2 ]Interview to explore further the experiences with rehabilitation training and equipment.
- 10-item questionnaire [ Time Frame: Week 2 ]Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Motor incomplete cervical SCI, neurologic levels C1-C7
- Atleast one arm with active shoulder flexion (reach with gravity eliminated) and atleast one grasp pattern/able to move fingers
- At least 6 months post injury
- At least one arm with greater than 50% normal passive range of motion in all upper limb joints, excluding the interphalangeal joints of the fingers
- Medically stable with no contraindications to the activities or to sitting
- 18 years of age or older
- Uncontrolled pain in the upper limbs
- Upper extremity amputations
- Unable to commit to at least 3 visits
- Surgical procedures (e.g., tendon transfers) or orthopedic trauma (e.g., fracture) within the past 3 months
- Other neurological conditions
- Mechanical Ventilation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000256
|United States, California|
|Orange, California, United States, 92866|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Ralph Marino, MD||Thomas Jefferson University|
|Responsible Party:||Thomas Jefferson University|
|Other Study ID Numbers:||
|First Posted:||June 27, 2019 Key Record Dates|
|Last Update Posted:||April 7, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Participant data from both sites will be pooled for analysis and reporting of results|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||1 year|
|Access Criteria:||De-identified data only|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Spinal cord injuries
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System